Remote Clinical Monitoring CRA II - Romania

Syneos Health, Inc.; Emilia-Romagna; Remote; EUR 11,000 - 17,000; Full time

Job summary

Syneos Health is seeking a CRA II for Romania-based, home-based work to monitor and manage clinical trial sites. You will perform site qualification, initiation, monitoring, and close-out visits remotely or on-site, ensuring GCP compliance and data integrity.

The role requires knowledge of GCP/ICH guidelines, strong communication and computer skills, and the ability to travel up to 75% regularly. You will collaborate with multidisciplinary teams to support IP handling, ISF/TMF management, and

Qualifications

• Bachelor’s degree or RN.
• Knowledge of Good Clinical Practice/ICH Guidelines.
• Must demonstrate good computer skills.
• Excellent communication, presentation and interpersonal skills.
• Ability to travel up to 75% regularly.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Verifies informed consent process and protects subject confidentiality; assesses factors affecting subject safety and data integrity.
• Per CMP/SMP: assesses site processes; conducts Source Document Review; verifies CRF data; applies query resolution remotely and on-site; ensures EDC compliance.
• May perform IP inventory, reconciliation and reviews storage and security; ensures proper labeling, import/export per protocol.
• Routinely reviews ISF for accuracy, timeliness and completeness; reconciles with TMF; archiving as required.
• Documents activities via letters, logs and reports; supports recruitment and retention; enters data into tracking systems.
• Manages project scope, budgets and timelines; adapts to changing priorities to meet goals.
• Acts as liaison with site personnel; ensures training and compliance of site team.
• Prepares for Investigator Meetings and sponsor meetings; participates in global monitoring meetings.
• Supports audit readiness and follow-up actions; maintains knowledge of regulatory requirements.
• Real World Late Phase: site lifecycle support from identification to close-out; potential junior staff training.

Skills

Good clinical practice knowledge

Computer skills

Communication skills

Presentation skills

Interpersonal skills

Travel readiness

Education

Bachelor’s degree or RN

Job description

Syneos Health is seeking a CRA II for Romania-based, home-based work to monitor and manage clinical trial sites. You will perform site qualification, initiation, monitoring, and close-out visits remotely or on-site, ensuring GCP compliance and data integrity.

The role requires knowledge of GCP/ICH guidelines, strong communication and computer skills, and the ability to travel up to 75% regularly. You will collaborate with multidisciplinary teams to support IP handling, ISF/TMF management, and